27 June 2020 - Swiss drugmaker Novartis has withdrawn an application for European approval of its Xiidra dry eye medicine after regulators concluded its effectiveness had not been demonstrated and that its benefits did not outweigh risks.

Novartis bought Xiidra from Takeda last year for $3.4 billion up front and $1.9 billion in potential milestone payments to refresh its eye drug portfolio. The drug is approved in the United States where it posted $90 million in first-quarter sales, and Novartis Chief Executive Vas Narasimhan had said he would explore approval elsewhere.

Before Novartis's withdrawal was announced on Friday, the European Medicines Agency (EMA) said it had already concluded that the Basel-based company had not shown that the medicine worked and raised concerns that Xiidra could not be authorized.

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